Status:
RECRUITING
Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer
Lead Sponsor:
Emory University
Collaborating Sponsors:
Bristol-Myers Squibb
National Cancer Institute (NCI)
Conditions:
Anatomic Stage I Breast Cancer AJCC V8
Anatomic Stage II Breast Cancer AJCC V8
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This clinical trial evaluates if in-person acupuncture or virtual acupressure therapy prevents aromatase inhibitor-associated joint pain in Non-Hispanic Black postmenopausal women with stage I-III (ea...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if initiation of in-person acupuncture or virtual acupressure sessions within 2 weeks of starting aromatase inhibitors (AI) will reduce the severity and incidence o...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Self-identified Non-Hispanic Black woman
- Postmenopausal status (\>= 12 months since last menstrual period, history of bilateral salpingo-oophorectomy, or estradiol, follicle-stimulating hormone \[FSH\], and luteinizing hormone \[LH\] levels consistent with menopause)
- Diagnosed with stage I-III HR+/HER2 negative (-) breast cancer
- Completed all phases of active therapy (e.g. surgery, chemotherapy, and/or radiation) at least 14 days before study enrollment
- Planned to start adjuvant AI
Exclusion
- Diagnosed with metastatic breast cancer
- Premenopausal status
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study
- Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy
- A history of or current CDK 4/6 inhibitor use
- A history of neoadjuvant AI use
- Use of adjuvant AI \> 14 days
- Received acupuncture within 60 days prior to start of study
Key Trial Info
Start Date :
December 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06534125
Start Date
December 12 2024
End Date
December 31 2026
Last Update
January 27 2025
Active Locations (4)
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1
Grady Health System
Atlanta, Georgia, United States, 30303
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342